CADD

Additional Manufacturer Narrative

ONE DEVICE WAS RECEIVED FOR EVALUATION. FUNCTIONAL TESTING WAS UNABLE TO DUPLICATE THE REPORTED ISSUE WHEN CONNECTED TO A KNOWN GOOD OPERATING PUMP; HOWEVER, UPON FURTHER INVESTIGATION, FAILURE OFTEN OCCURS WITH NEWLY BUILT PUMPS. THE ROOT CAUSE WAS UNABLE TO BE DETERMINED.

Description of Event or Problem

IT WAS REPORTED THAT THE WIRELESS COMMUNICATION MODULE HAD A DAMAGED ANTENNA COVER ASSEMBLY SCREWS AND CANNOT BE DISASSEMBLED TO CONNECT THE BATTERY. THE EVENT TOOK PLACE IN THE HOSPITAL. IT WAS AN OUT OF BOX FAILURE. THERE WAS NO PATIENT INVOLVEMENT. EVALUATION OF THE DEVICE IDENTIFIED THE MODULE WAS OPERATING AS INTENDED WHEN TESTED ON A KNOWN GOOD OPERATING SOLIS PCEA PUMP BUT, WHEN ATTACHED TO NEWLY BUILT PUMPS, IT RETURNED THE SAME FAILURE. THE PUMP WOULD INTERMITTENTLY FAIL TO DETECT THE WIRELESS COMMUNICATION MODULE BATTERY DURING THE POWER-UP PROCESS RESULTING IN WIRELESS MODULE INTERMITTENT CONNECTION WITH THE PUMP MESSAGE WHEN POWERING-UP WITH THE AC POWER CORD PLUGGED IN.